BEUDAMED
    FDA Adverse Event Other Summary report: N

    HONEYWELL

    MDR report key: 2442334 · Received February 1, 2012

    Report

    Report Number
    1314800-2012-00001
    Event Type
    Other
    Date Received
    February 1, 2012
    Date of Event
    January 13, 2012
    Report Date
    January 30, 2012
    Manufacturer
    KAZ INC
    Product Code
    BTT
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THE HUMIDIFIER FILTER BECAUSE MOLDY WHILE IN USE. THE MOLD FROM THE UNIT CAUSED A BACTERIAL INFECTION IN HER CHILD WHICH REQUIRED MEDICAL ATTENTION. THE MOLD IS ALSO BOTHERING HER EYES. AS THIS HUMIDIFIER HAS A PERMANENT FILTER IT REQUIRED WEEKLY CLEANING TO PREVENT MOLD AND MILDER PER THE PROPER USE INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HONEYWELL HUMIDIFIER BTT KAZ INC HCM-800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other